Drugs

Sanrace Biotechnology Co. CGMP Violations

An FDA review of records requested from Sanrace Biotechnology Co. in Zhejiang Province, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/22 Warning Letter says the specific violations were:

failure to conduct at least one test to verify the identity of each component of a drug product;
failure to establish written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
failure to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

FDA recommends that Sanrace engage a qualified consultant to perform a six-system audit of its entire operation, assist it in meeting CGMP requirements, and evaluate the completion and efficacy of its corrective and preventive actions before the firm pursues resolution of its compliance status with the agency.

The agency placed all of Sanrace’s drugs and drug products offered for import into the U.S. on a 9/21 Import Alert.

Sanrace was told to promptly address the violations and ensure that adequate resources are allocated to fully address the violations and prevent their recurrence.

FDA Warns Amgen Over Misleading Vectibix Promotional Video

FDA has issued a Warning Letter to Amgen over a promotional video for its colorectal cancer drug Vectibix (panitumumab) because it omitted all safety information and failed to disclose important limitations on the drug’s approved uses. In the just-posted 8/12 Warning Letter, CDER’s Office of Prescription

Court Rejects Novo Nordisk Bid to Block Lilly’s GLP-1 Advertising

A federal judge has denied Novo Nordisk’s request for a preliminary injunction blocking Eli Lilly from running allegedly misleading advertisements comparing its GLP-1 drugs Zepbound and Mounjaro with Novo’s Wegovy and Ozempic, finding that Novo failed to demonstrate irreparable harm. In a 10/26 opinion, U.S.

FDA Releases 79 More Form 483 Inspection Records

FDA published another 79 Form 483 inspection records on 10/26 through the Office of Inspections and Investigations FOIA Electronic Reading Room, continuing a series of substantial disclosures of previously unavailable inspection documents. Their availability is part of the agency’s expanded transparency initiative (see earlier story), but a significant

AdvaMed Urges FDA to Use Existing Regulatory Framework for GenAI

AdvaMed is asking FDA to build on its existing regulatory framework for generative AI (GenAI)-enabled medical devices instead of creating new frameworks that could hinder innovation. In comments responding to an FDA discussion paper, AdvaMed said utilizing GenAI in medical devices “should not fundamentally alter the core principles that

Read more

FDA Warns Amgen Over Misleading Vectibix Promotional Video

Court Rejects Novo Nordisk Bid to Block Lilly’s GLP-1 Advertising

FDA Releases 79 More Form 483 Inspection Records

AdvaMed Urges FDA to Use Existing Regulatory Framework for GenAI